DRUG
LIXISENATIDE AVE0010
Pharmaceutical form:solution Route of administration: subcutaneous
Status
Terminated
Phase
Phase 2
Enrollment
2
Locations
0
Results
Not posted
Publications
0
Study summary
Primary Objective: To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides. Secondary Objectives: The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation. The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity. The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.
Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (Final/End-of-treatment Visit).
Interventions
DRUG
Pharmaceutical form:solution Route of administration: subcutaneous
DRUG
Pharmaceutical form:tablet Route of administration: oral
Timeline
First posted
Oct 24, 2014
Study start
Apr 2015
Primary completion
Aug 2015
Study completion
Aug 2015
Results posted
Not reported
Registry updated
Jan 30, 2017
Outcomes
Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)
Time frame · After 10 weeks of treatment
Change from baseline in plasma triglyceride
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in plasma cholesterol
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in APO B48
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in free fatty acid levels
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in lipoprotein distribution
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in LDL oxidation
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in postprandial plasma glucose
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in insulin
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in C-peptide
Time frame · 2 days after the basal test and after 10 weeks of treatment
Change from baseline in low grade inflammation (cytokines and stress oxidative markers)
Time frame · 2 days after the basal test and after 10 weeks of treatment
Eligibility
Inclusion criteria: Male and female patients, 18-70 years of age. Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index \[BMI\] \>30 kg/m\^2) and the following other abnormalities: * Abdominal obesity (waist circumference \>102 cm in men and \>88 cm in women). According to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001). * Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might reasonably suggest more stringent A1c goals \[such as 6.5%\] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease). * Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL, cholesterol \<300 mg/dL. In order to exclude patients who might be suffering from a primitive dyslipidemia). * Low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol \<40 mg/dL in men and \<50 mg/dL in women). Written informed consent. Exclusion criteria: Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (Thyroid Stimulating Hormone \[TSH\] \>5 mU/L with clinical symptoms of hypothyroidism). Hepatic disease (Aspartate Aminotransferase \[ASAT\] or Alanine Aminotransferase \[ALAT\] \>2 times the upper limit of normal). Renal disease (serum creatinine \>1.7 times the upper limit of normal). A history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment. History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg. Triglycerides \>600 mg/dL. History of chronic pancreatitis or of idiopathic acute pancreatitis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
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